NCT03966924

The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Completed NA Results posted Last updated 11 May 2021

What this trial tests

NA trial testing Rotational fractional resection (1.5mm Diameter Device) in Skin Laxity in 2 participants. Completed in 16 October 2019.

Timeline

20 March 2019

Primary endpoint
16 October 2019

16 October 2019

Quick facts

Lead sponsor	Recros Medica, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	20 March 2019
Primary completion	16 October 2019
Estimated completion	16 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Rotational fractional resection (1.5mm Diameter Device)

Conditions studied

• Skin Laxity — all drugs for Skin Laxity →
• Lipodystrophy — all drugs for Lipodystrophy →

Sponsor

Recros Medica, Inc.

Who can join

30 and older, any sex, with Skin Laxity or Lipodystrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale Primary · 90 days post treatment

Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	2

Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline Secondary · 90 days post treatment

Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied," "satisfied," or "very satisfied").

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	2

Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale Secondary · 90 days post treatment

Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days post treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rotational Fractional Resection (1.5mm Diameter Device)

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (1 terms — click to expand)

Reaction	System	Rotational Fractional Rese…
Skin irritation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03966924 adverse events section.

Sponsor's own description

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.